Off-label Use of Sildenafil:A Retrospective Survey / 医药导报

ABSTRACT

Objective To understand the situation of off-label use of sildenafil, so as to provide reference for developing off-label drug use policy. Methods A stratified random sampling method was used to collect prescription data of sildenafil in Guangdong Women and Children Hospital in 2015. The off-label drug use situation was analyzed according to drug labels. The situations of drug use in all departments were summarized, and off-label drug use occurrences were analyzed.Results A total of 1044 prescriptions with sildenafil were collected and analyzed to discover the occurrence of off-label use was up to 69. 54%. The top 3 departments of off-label use of sildenafil were assisted reproductive center, heart center and neonatal intensive care unit (NICU). The top 3 types of off-label use were non-indication(50. 35%), over drug population(31. 76%) and over drug administration(17. 89%). The top 3 diseases for non-indications were infertility, pulmonary hypertension and congenital heart disease. Conclusion Sildenafil off-label use was common in Guangdong Women and Children Hospital in 2015, especially in assisted reproductive center, heart center, and NICU. The result suggests that more clinical studies about sildenafil on cardiovascular system are expected to provide more evidence for drug use, so as to ensure the safety of drug use in special populations and avoid potential medical risk.